Kornimate/medical-research-clean huggingface dataset:
targeting er-golgi homeostasis in an advantageous therapeutic strategy in lung cancer

Conditions: The Combined Effect of Hsp90 Inhibitor and HDAC/Proteasome Inhibitors on Lung Cancer Cell Fate and ER-Golgi Homeostasis Will be Examined.

Summary: lung cancer remains the most common cause of cancer-related death in the world. the major advances in treatment of lung cancer have brought only minor improvements in survival therefore novel systemic treatment methods are urgently needed. protein levels are regulated by the protein homeostasis network that generates and protects the protein fold (er and golgi included). the heat shock protein 90 (hsp90) is an essential molecular chaperon involved in the posttranslational folding and stability of proteins. hsp90 inhibition leads to accumulation of unfolded proteins and er stress. the therapeutic efficacy of such inhibition may be augmented by co-administering it with other drugs that disrupt er-golgi homeostasis like histone deacetylase (hdac) or proteasome inhibitors. er-golgi homeostasis disruption affects a wide network of proteins and pathways as such affords a systemic target. thus, the investigators aimed to examine the effect of combined treatment of hsp90 antagonist with proteasome or hdac inhibitors on human lung cancer cell lines and primary cells.


Eligibility criteria:
inclusion criteria: * patients with proved diagnosis of lung carcinoma that are candidats for radical surgical treatment exclusion criteria: * patients with suspicion for lung carcinoma without pathologycal diafnosis before surgery
clemastine fumarate in the treatment of neurodevelopmental delays in williams syndrome

Conditions: Williams Syndrome; Child; Neurodevelopmental Delay

Summary: this study focuses on therapeutic targets for cognitive, motor, and social impairments in williams syndrome by reversing brain myelin defects caused by gtf2i. the primary objective of the study was to test and evaluate the initial efficacy and safety of clomastine fumarate in the treatment of williams syndrome.

the primary objective of this study was to evaluate the initial efficacy and safety of clomastine fumarate in the treatment of williams syndrome. the secondary objective is to study clomastine fumarate in relation to mechanisms of action, safety, and/or pathological mechanisms. this study was an open-label study with a randomized, cross-over, placebo-controlled design. each participant will be randomly assigned to two groups through baseline assessment (see study results), with group a receiving the fda-approved drug clemastine at a weight-dependent dose (see dosing table below) for the first cycle and placebo for the second cycle. group b will be treated with placebo for the first cycle and the fda-approved drug clemastine for the second cycle.

Eligibility criteria:
inclusion criteria: 1. age 3-6 years old; 2. positive fluorescence in situ hybridization (fish) test confirmed williams syndrome; 3. gtf2i gene mutation was detected by whole exon; 4. heart safety variables are normal (e.g. normal ecg, blood pressure 120-129/80-84) exclusion criteria: 1. ws patients with other gene mutations; 2. used antihistamines, monoamine oxidase inhibitors, barbiturates and sedatives, as well as drugs affecting cognitive behavior, limb movement, white matter myelin, and mri within 2 months before enrollment; 3. patients with narrow-angle glaucoma, narrow peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy and bladder neck obstruction; accompanied by severe immunodeficiency disease; 4. allergic to clomastine fumarate or other arylalkylamine antihistamines or any receptor; 5. according to the recent interpretation of mri and neuroradiology experts or ws, there are obvious brain lesions that are not related to ws disease; 6. clinically significant metabolic, hematological, liver, immune, urinary, endocrine, neurological, pulmonary, psychiatric, skin, allergic, renal, or other major diseases that may affect the interpretation of study findings or patient safety in ws's judgment;

Keywords: clemastine fumarate williams syndrome mri
mind-body resiliency intervention for fear of cancer recurrence

Conditions: Cancer; Coping Skills; Coping Behavior

Summary: the purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (for) among cancer survivors.

this is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (in focus) among cancer survivors with clinically elevated fear of recurrence (n = approximately 64). patient-reported outcomes on psychological and behavioral outcomes will be measured at t0 (baseline), t1 (post-intervention/approximately two months post-baseline), and t2 (three months post-intervention/approximately five months post-baseline). exit interviews will be conducted after the t1 survey. participants are expected to be in the study for approximately five months.

Eligibility criteria:
inclusion criteria: * history of non-metastatic, localized, or regional solid or blood malignancy(ies) * completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy * age ≥18 years * elevated fear of recurrence (fcri severity score ≥16) * mgb/bidmc medical record number (mrn) exclusion criteria: * self-reported inability to speak and write in english * undertreated serious mental illness as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year * inability to access technology and/or sufficient internet to participate virtual groups sessions

Keywords: cancer coping skills coping behavior
evaluation of soluble epoxide hydrolase (s-eh) inhibitor in patients with mild to moderate hypertension and impaired glucose tolerance

Conditions: Hypertension; Impaired Glucose Tolerance

Summary: the purpose of this study is to determine the safety and efficacy of ar9281, a novel s-eh enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * mild to moderate hypertension * naive to antihypertensive medication or on two or less antihypertensive medications * impaired glucose tolerance * mild obesity exclusion criteria: * diagnosis of type 1 or type 2 diabetes * history of severe heart failure * ast, alt levels more than twice the normal range

Keywords: hypertension impaired glucose tolerance s-eh enzyme inhibition pre-diabetes
clinical investigation of the da vinci surgical system

Conditions: Thymoma; Mediastinal Tumor; Gynecologic Disease; Gynecologic Cancer; Pelvic Organ Prolapse; Prostate Disease; Prostate Cancer; Inguinal Hernia; Ventral Hernia; Obesity, Morbid

Summary: this prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da vinci surgical system in performing robotic-assisted surgical procedures.


Eligibility criteria:
pre-operative inclusion criteria: * age 21 years or older * per study investigator's discretion, subject is a suitable candidate to undergo multiport robotic-assisted surgery for the study specified procedure as a primary procedure pre-operative exclusion criteria: * subject is pregnant or suspected to be pregnant or breastfeeding * subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete quality data * subject is currently participating in or has participated in a study of an investigational agent or a significant risk investigational device study within the past 6 months * subject belongs to vulnerable population. * subject is contraindicated for anesthesia or surgery * subject has had previous neoadjuvant therapy, previous chemotherapy, immunotherapy, and/or radiation therapy for treatment of the cancer to be resected within the past 6 months
efficacy of implantable defibrillator therapy after a myocardial infarction

Conditions: Myocardial Infarction; Sudden Death

Summary: this study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

the refine icd trial will assess whether prophylactic icd therapy, guided by non-invasive risk assessment tools, reduces mortality in mi survivors with better-preserved lv function.

Eligibility criteria:
site investigators are responsible for screening. subjects must meet all inclusion criteria. subjects with any exclusion criteria will be excluded. initial inclusion criteria (eligibility for holter screening). * 18 - 80 years old at time of consent * history of mi ≥ 2 months prior to screening based on esc/accf/aha/whf criteria (both stemi and nstemi subjects are eligible) * appropriate post-mi management including revascularization where indicated * no contra-indication for transvenous icd placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.) * lvef 36% - 50% measured at least 40 days after a confirmed mi ≥ 3 months after coronary angioplasty or coronary bypass surgery and within the following time windows: * lvef ≤ 7 months of screening visit if index mi was ≤ 1 year of enrolment * lvef ≤ 13 months of screening visit if index mi was \> 1 \& \< 3 years of enrolment * lvef ≤ 25 months of screening visit if index mi was ≥ 3 years of enrolment * proven, necessary or appropriate medications (e.g. beta-blocker, ace inhibitor / arb, statin, and anti-platelet) * in normal sinus rhythm (ecg documented) ≤ 8 weeks prior to the screening holter * written informed consent * able and willing to complete the screening holter, including the six-minute hall walk additional inclusion criterion (eligibility for randomization). * abnormal hrt \& twa (core lab interpretation) on holter performed at least 2 months after the index mi and the specified time after coronary revascularization * in normal sinus rhythm (ecg documented) within 8 weeks prior to the screening holter * in normal sinus rhythm for ≥ 18 hours of the 24 hr screening holter as determined by the study holter core lab exclusion criteria (randomization or registry). * use of antiarrhythmic drugs * clinical indication for permanent pacemaker or a cardiac resynchronization device * clinical indication for an icd or cardiac resynchronization icd * prior implantation of a pacemaker, icd, or cardiac resynchronization device * any condition, in the investigator's judgment, that would limit life expectancy to \< 12 months * chronic renal failure (hemodialysis or peritoneal dialysis) * active ischemia that is amenable to revascularization if not previously revascularized * participation in another trial that may interfere with the refine icd results. * pregnancy * inability to comply with the follow-up schedule

Keywords: noninvasive assessment holter
comparison of two pericardial bioprostheses in avr

Conditions: Aortic Valve Disease

Summary: the purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, avalus and carpentier edwards perimount magna ease.

this trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. patients were randomized by use of a randomization table. bioprosthesis was chosen between avalus or carpentier edwards perimount magna ease according to the randomization result. the primary end point is postoperative 1-year transvalvular mean pressure gradient. the secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events.

Eligibility criteria:
inclusion criteria: * patients who are going to undergo aortic valve replacement with bioprosthesis exclusion criteria: * heart failure with severe lv dysfunction (lv ef \<30%) * active infective endocarditis * with other critical cardiovascular disease (e.g. acute aortic dissection) * with other critical comorbities by which the expected life span is less than 1 year * inadequate participant by the researcher's discretion

Keywords: aortic valve replacement bioprosthesis
association of jaw dysfunction with neck disability in subjects with chronic cervical spine disorders

Conditions: Musculoskeletal Pain; TMJ Pain; Cervical Pain

Summary: since tmj and cervical pain incidence are rising and both structures are highly interrelated anatomically and functionally. and yet no standard protocol for tmd therapy the objective of this study is to state if there is a correlation between tmd and cervical dysfunction. to help reach a better diagnosis and a more holistic treatment. forty volunteers (15 male and 25 female) between the ages of 20 to 40 were recruited. cervical rom was measured in all directions (rotation, flexion and extension, and sidebending) by crom device, and a 10 cm plastic ruler marked in both centimeters and millimeters was used to measure tmj vertical opening.

background: the incidence of temporomandibular dysfunction has been rapidly increasing in the past years especially among women and still no definite treatment protocol and that's due to the inter lapping of anatomy and neurology of this joint with other structures all over the body. the cervical spine dysfunction has a high incidence as well, and they are common to coexist as they are highly interrelated. objective: the objective of this study is to emphasize the interrelation between cervical dysfunction and tmj dysfunction by examining the relationship between cervical spine rom and tmj vertical opening rom to provide better recognition of the etiology of tmj dysfunction thus a holistic intervention. materials and methods: it is a bivariate correlational research design. forty subjects between the age of 20 -40 years (15male/ 25females) were recruited. cervical rom was measured by crom device for all 6 cervical movements. the tmj vertical mouth opening was measured by a 10 cm ruler. the crom will be used consistent with standard clinical procedures, with 3 takes for each measurement to decrease human error. the measurements were taken one shot.

Eligibility criteria:
inclusion criteria: 1. between the ages of 20 and 40 2. female and male 3. suffering from a reduced cervical rom 4. no reported tmj pain exclusion criteria: * 1) tumor (anywhere in the body) 5. recent trauma to the neck, torso or upper limb 6. active inflammation in the cervical region, upper thoraxic spine and chest or upper limb 7. recent use of orthodontics prostheses
hydronidone for the treatment of liver fibrosis associated with chronic viral hepatitis b phase 3 trial.

Conditions: Liver Fibrosis

Summary: this study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study. the main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis b liver fibrosis.

248 patients with chronic viral hepatitis b liver fibrosis were enrolled in this 52-week study, and randomized into hydronidone or placebo group. each group has 124 patients. both groups were treated with entecavir antiviral basic therapy.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited. 2. history of chronic hepatitis b and/or hepatitis b surface antigen (hbsag) positive≥6 months. 3. percutaneous liver biopsy confirmed liver fibrosis (ishak score ≥3). 4. positive hbv dna. 5. alt \< 8 x uln (standard upper limit). 6. no antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment. 7. 3 months before inclusion, he/she had not received any of the following proprietary chinese medicines that may have anti-fibrosis effects: fuzheng huayu capsule (tablet), anluo huayu pill, compound bijiaruangan tablet, etc. 8. the subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan. 9. before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form. exclusion criteria: 1. massive upper gastrointestinal hemorrhage within 3 months before enrolment. 2. total bilirubin (tbil) \> 3×uln, or 3×uln \ 2×uln. 3. afp \> 100 μg/l although there was no indication of liver cancer. 4. platelets (plt) ≤60×109/l. 5. prothrombin activity (pta) \ 1.5. 6. imaging showed obvious space-occupying lesions in the liver, suggesting tumor. 7. body mass index (bmi) \> 30 kg/m2. 8. patients with decompensated liver cirrhosis and liver malignant tumor. 9. patients with chronic hepatitis c or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis. 10. serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders . 11. women who are pregnant and/or breastfeeding. 12. have participated in clinical trials of other drugs in the last 3 months. 13. the investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.
impact if desflurane preconditioning on the content of the phospho-gsk-3b in the rat's neurons in the model of i/r

Conditions: Heart Arrest

Summary: endpoint implementation of reactions initiated by ischemia is the mitochondrial transition pore permeability. mitochondria pores opening results in a release of factors triggering apoptosis primarily the cytochrome с inhibition of the pores opening protects ischemic damage of the cells. the key enzyme regulating the mitochondrial permeability transition pore is gsk-3b: the phosphorylation of the enzyme inactivates the enzyme and prevents pore opening. aim of studi is to determine content of the phosphorylatcd gs k-3b in neurons of rat brain in the model of total tschemia/reperfusion.

endpoint implementation of reactions initiated by ischemia is the mitochondrial transition pore permeability. mitochondria pores opening results in a release of factors triggering apoptosis. primarily the cytochrome с inhibition of the pores opening protects ischemic damage of the cells. the key enzyme regulating the mitochondrial permeability transition pore is glycogen synthase-kinase 3b (gsk-3b): the phosphorylation of the enzyme inactivates the enzyme and prevents pore opening. we have shown in previous study that preconditioning with sevoflurane increases the content of the phosphorylated form of 6sk-3b and protects the mitochondria of neurons in rats brain during ischemia/reperfusion. aim of studi is to determine content of the phosphorylated gs k-3b in neurons of rat brain in the model of total ischemia/reperfusion influenced by: 1 mac desflurane vs control group; 1 mac desflurane vs 1 mac sevoflurane and 1 mac desflurane vs training ischemia.

Eligibility criteria:
inclusion criteria: * breeding albino male rats weigh from 180 to 240 g exclusion criteria: * n/a

Keywords: desflurane preconditioning
investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.

Conditions: Hepatobiliary Disorders; Non-alcoholic Steatohepatitis

Summary: investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis


Eligibility criteria:
inclusion criteria: - informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - male or female, aged 18-75 years (both inclusive) (for japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - local histological diagnosis of nash followed by histological confirmation of nash based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - histologic evidence of nash based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - nash fibrosis stage 1, 2 or 3 according to the nash crn fibrosis staging system based on central pathologist evaluation exclusion criteria: - known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence\* or narcotics. (\* = assessed by the alcohol use disorders identification test (audit questionnaire)) - diagnosis of type 1 diabetes according to medical records - hba1c above 10% at screening - history or presence of pancreatitis (acute or chronic) - calcitonin equal or above 50 ng/l at screening - family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. family is defined as a first degree relative - body mass index (bmi) ≤ 25.0 kg/sqm at the screening visit (visit 1) - female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)